BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 1913474 · Received November 12, 2010

    Report

    Report Number
    3004742046-2010-00535
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ABSOLUTE 10 MM X 30 MM WAS RETURNED WITH BLOOD ON THE HANDLE AND IN THE DISTAL OUTER SHEATH, CONSISTENT WITH HANDLING. THERE WAS NO SALINE VISIBLE. THE 20 MM ABSOLUTE STENT IMPLANT USED IN THIS CASE WAS RETURNED ON THE OUTSIDE OF THE PROXIMAL HALF OF THE 30 MM STENT IMPLANT. THE PROXIMAL END OF THE STENT IMPLANT WAS SLIGHTLY SMASHED. THE MIDDLE OF THE 30 MM STENT IMPLANT WAS STRETCHED. THE DISTAL OUTER SHEATH WAS RETRACTED 10 CM FROM THE CROWN OF THE TIP. THERE WERE MULTIPLE KINKS THROUGHOUT THE ENTIRE SHAFT AND DISTAL OUTER SHEATH. THE OUTER MEMBER WAS BUNCHED FOR A LENGTH OF 1 MM, 51 CM DISTAL TO THE STRAIN RELIEF TUBING. THE HANDLE WAS IN THE UNLOCKED POSITION. THERE WAS NO OTHER DAMAGE NOTED TO THE SELF EXPANDING STENT SYSTEM (SESS). THE HANDLE WAS OPENED AND THE PROXIMAL END OF THE RACK WAS 1 CM DISTAL TO THE PROXIMAL END OF THE HANDLE, SUGGESTING THAT THE THUMBWHEEL HAD BEEN ROTATED. THERE WAS NO DAMAGE NOTED TO THE INTERNAL MECHANISMS. IT WAS REPORTED THAT THE STENT PREMATURELY DEPLOYED INSIDE THE SHEATH, A NON-BLEED BACK 18F SHEATH. ADDITIONAL CLARIFICATION RECEIVED INDICATED THAT THERE WAS NO VISIBLE EVIDENCE ON THE STENT TIP OF ANY PROBLEM PRIOR TO INSERTION. HOWEVER, AFTER THE FIRST ABSOLUTE SELF EXPANDING STENT SYSTEM WAS INSERTED INTO THE SHEATH, IT WAS THOUGHT THAT IT WAS DEFECTIVE AS THERE WAS NO STENT ATTACHED. A SECOND DEVICE WAS USED AND WHEN THE STENT PREMATURELY DEPLOYED IN THE SHEATH, IT WAS FOUND TO HAVE BEEN INSERTED INTO THE FIRST STENT. BASED ON THE REPORTED INFORMATION AND CONDITION OF THE RETURNED PRODUCT, IT APPEARS THAT THE STENT LIKELY PREMATURELY DEPLOYED DUE TO INTERACTION WITH THE NON-ABBOTT SHEATH. THE DAMAGE NOTED TO THE DISTAL OUTER SHEATH FURTHER INDICATES THAT THE UNIT WAS BEING FORCED THROUGH A SMALLER INNER DIAMETER CAUSING THE STENT TO UNSHEATH AND DEPLOY. THERE WAS NO DAMAGE REPORTED DURING THE PRIOR TO USE INSPECTION AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. POTENTIAL FACTORS WHICH COULD CONTRIBUTE PREMATURE DEPLOYMENT PRIOR TO USE INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, INADVERTENTLY PULLING ON THE TIP OF THE SESS DURING REMOVAL OF THE TIP MANDREL, INSUFFICIENT SUPPORT DURING PREP, KINKS IN THE SHAFT, INTERACTION DURING LOADING ONTO A GUIDE WIRE, OR INTERACTIONS WITH THE INTRODUCER SHEATH AND/OR ASSOCIATED DEVICES DURING INSERTION. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS. ADDITIONALLY, THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED AND THE LOT RELEASE TESTING RESULTS WERE REVIEWED MET ALL RELEASE CRITERIA. THE REPORTED PREMATURE DEPLOYMENTS AND SEVERE DAMAGE TO ALL THREE UNITS APPEAR TO BE RELATED TO CASE CIRCUMSTANCES AND/OR USER MISHANDLING. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. DURING PRODUCTION ALL SHEATHED STENTS ARE VISUALLY INSPECTED FOR STENT LOCATION BETWEEN THE MARKERS AND VERIFICATION THAT THE STENT IS FULLY COVERED WITHIN THE DISTAL SHEATH. PRODUCTION ALSO INSPECTS ALL SHAFTS VISUALLY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED; HOWEVER, THE INVESTIGATION IS NOT YET COMPLETE. A F/U REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFO. THE OTHER ABSOLUTE DEVICE ((B)(4)) REFERENCED IN B5 AND D11 IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABSOLUTE STENT PREMATURELY DEPLOYED. ONE ON THE CATH LAB TABLE AND THE OTHER TWO INSIDE THE SHEATH (18FR GORD SHEATH), A NON BLEED BACK SHEATH. REPORTEDLY, THERE WAS NO RESISTANCE ENCOUNTERED PRIOR TO PREMATURE DEPLOYMENT OF STENTS. A FOURTH STENT (ABSOLUTE PRO 10X40) WAS USED TO COMPLETE THE PROCEDURE. REPORTEDLY, THERE WERE NO PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL EVENT OR PT INFO WAS PROVIDED.

    Description of Event or Problem · 1

    CLARIFICATION RECEIVED INDICATED THERE WAS NO VISIBLE EVIDENCE ON THE STENT TIP OF ANY PROBLEM PRIOR TO INSERTION. HOWEVER, AFTER THE FIRST ABSOLUTE SELF EXPANDING STENT SYSTEM WAS INSERTED INTO THE SHEATH, IT WAS THOUGHT THAT IT WAS DEFECTIVE AS THERE WAS NO STENT ATTACHED. A SECOND DEVICE WAS USED AND WHEN THE STENT PREMATURELY DEPLOYED IN THE SHEATH, IT WAS FOUND TO HAVE BEEN INSERTED INTO THE FIRST STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE .035 SELF EXPANDING STENT SYSTEM SELF-EXPANDING STENT SYSTEM FGE ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 0060251

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR